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Manager, Regulatory Affairs

10+ years
Not Disclosed
10 July 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

When our values align, there's no limit to what we can achieve.

At Parexel, we share a unified goal: improving global health. From clinical trials to regulatory consulting and market access, every clinical development solution we provide is driven by a deep conviction in our mission.

Each of us, regardless of our role at Parexel, contributes to developing therapies that ultimately benefit patients. We approach our work with empathy, taking it personally, and are committed to making a difference.

Key Qualifications and Experience:

  • Over 10 years of relevant experience in Clinical Trial Regulatory Submissions.
  • Proven track record in managing clinical trial studies and serving as a Regulatory Lead for global trials, with specific exposure to the European market.
  • Expertise in handling the CTIS database and submitting under EU CTR is highly desirable.
  • Provides expert guidance to project team members.
  • Works within broad project guidelines, facilitating issue and conflict resolution.
  • Prioritizes personal workload and may prioritize the project team's workload to achieve project scope and objectives.
  • Seizes opportunities to enhance project efficiency, results, or team performance and proactively takes action.
  • Utilizes information from previous projects or client work to efficiently complete assigned project activities and facilitate business decisions.
  • Delivers quality work that meets client expectations and reviews colleagues' work for content and quality to ensure client and Parexel standards are met.
  • Assesses project issues and develops strategies to achieve productivity, quality, and project goals and objectives.
  • Actively manages performance, including typical HR activities for direct reports (e.g., performance reviews, salary actions, bonuses, scorecards).
  • Ensures Parexel policies and procedures are communicated to line personnel in accordance with local country regulations.
  • Provides a comprehensive range of technical and business consulting services, primarily in areas with clear policy or precedent.
  • Defines self-development activities to stay current in the industry (e.g., maintains membership in relevant industry and/or scientific/technical associations).

Our commitment to improving health worldwide unites us, driving our dedication to deliver impactful and meaningful results. Join us at Parexel, where your work makes a difference.